Study of Alvimopan for the Management of Opioid-Induced Postoperative Bowel Dysfunction/ Postoperative Ileus - Full Text View

Sponsors and Collaborators:	Adolor Corporation GlaxoSmithKline
Information provided by:	Adolor Corporation
ClinicalTrials.gov Identifier:	NCT00388479

Purpose

Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention and bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).

Condition	Intervention	Phase
Ileus	Drug: Alvimopan	Phase III

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Alvimopan LY246736

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus

Further study details as provided by Adolor Corporation:

Primary Outcome Measures:

Acceleration of gastrointestinal recovery

Secondary Outcome Measures:

Time until ready for discharge based upon recovery of GI function
Severity of GI symptoms
Pain
Opioid Consumption
Time to tolerate liquids
Need for reinsertion of nasogastric tube
Time until discharge order is written

Estimated Enrollment:	666
Study Start Date:	December 2001
Study Completion Date:	November 2003
Primary Completion Date:	November 2003 (Final data collection date for primary outcome measure)

Detailed Description:

Postoperative ileus (POI) is a temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. No drug therapy has been shown to consistently shorten the duration of POI. This study is designed to demonstrate that alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the recovery of GI function in patients undergoing bowel resection or hysterectomy.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is scheduled for a partial small/large bowel resection with primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy
Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids

Exclusion Criteria:

Subject is scheduled for a total colectomy, colostomy, ileostomy
Subject has complete bowel obstruction
Subject has recently been on an acute course (1-10 days) of opioid analgesics and has not been off all opioids for at least 1 week prior to surgery Subject has been on chronic (>10 days) opioid analgesics and has not been off all opioids for at least 2 weeks prior to surgery.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388479

Locations

United States, Pennsylvania
Various
Exton, Pennsylvania, United States, 19341

Sponsors and Collaborators

Adolor Corporation

GlaxoSmithKline

Investigators

Study Director:

Adolor Corporation

More Information

Adolor Corporation home web page address This link exits the ClinicalTrials.gov site

Publications of Results:

Viscusi ER, Goldstein S, Witkowski T, Andonakakis A, Jan R, Gabriel K, Du W, Techner L, Wallin B. Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study. Surg Endosc. 2006 Jan;20(1):64-70. Epub 2005 Dec 7. Erratum in: Surg Endosc. 2006 Mar;20(3):537.

Study ID Numbers:	14CL308
Study First Received:	October 12, 2006
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00388479
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Intestinal Obstruction
Ileus
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009